Clinical Trials Day
PRA Health Sciences
PRA Health Sciences

Have you ever considered how different medicine would be if there were no clinical trials?

For starters, it might cease evolving and being effective. Further, it might prevent doctors from being able to help more people and help them find alternative treatments for their patients. That’s because clinical trials are meant to open up new, unexplored horizons of medicine with the help of inventing innovative treatments.

May 21 is Clinical Trials Day, celebrated worldwide to spread awareness of clinical studies, their significance in the area of healthcare, and their benefits. But it’s not only about the research process and its output; it’s also about the professionals who are dedicated to their work and are committed to international efforts to ensure safe and good-quality medicines.

Our Mariia Iaroshenko, an in-house CRA in Ukraine, shares her views on clinical trials and her work:

On the whole, any medical research represents the faith for the cure of diseases and the relief from severe illnesses. Without a shadow of doubt, conducting clinical trials enhances knowledge on the root cause of health problems and on ways to fight a malady. Clinical trials also facilitate sharing experience and good practices among representatives of medical science and allows physicians to compare results of the impact of various medicinal products on similar diseases. But they can also bring peace of mind to sufferers and their families. Essentially, clinical trials are of paramount importance to both the present and the future, because they provide a tremendous opportunity for improving health of the global population.

Clinical research as a career

My own journey in clinical operations dates back to early 2013 when I was honored to obtain the position of an in-house CRA (IHCRA). From the very beginning I knew that it was essential to me to gain knowledge, to practice it, and to continue growing, because my accomplishments and the success of the team I represented and worked with were connected, and I needed to keep moving; to make mistakes even, but never quit. I was promoted to the Senior IHCRA, had Star awards, and took part in the FDA inspection. Perhaps more importantly, I had earned the respect of investigators and colleagues I cooperated with side-by-side.

Frankly speaking, I would compare the course of the IHCRA day with setting up a puzzle. You have different pieces in your hands. How you structure your work depends on the project you have. For instance, the main objective of start-up is to reach Principal Investigators for them to confirm if they are eager to participate in the trial, to sign study related forms, to complete questionnaires, to provide CVs, etc. You need to keep everything under control and follow up so that nothing has been lost at a very early stage because the initiation of the start-up project constitutes a fundamental factor. If the study is in maintenance, the IHCRA operates and builds a specific strategy to focus on a broad and a multi-pronged cooperation with sites, because multitasking comes into force. In the meantime, you pursue various submissions to the relevant authorities, dispatch study-required materials to sites, upload documents, assist CRAs when they are at IMVs, call sites for them to close queries, enter data into eCRF…and there’s still more on the to-do-list!

Essentially, clinical trials are of paramount importance to both the present and the future, because they provide a tremendous opportunity for improving health of the global population.

When the IHCRA is assigned for feasibility, he or she searches, selects and acquires the best sites to be approved for taking part in the trials; these decisions impact the trials’ performance. To me, the internal dynamics of the clinical trials process and procedures is really exciting and meaningful.

IHCRA should be a communication strategist in terms of an open dialog with investigators at each clincal trial stage; feasibility, start-up and maintenance, in order to make people interested in the proposals you make. Your goal is ultimately to keep the participants of clinical trials engaged and motivated.

Planning and punctual implementation of all planned affairs plays the key role in the every day routine of the IHCRA. You always must manage to be two steps forward to meet the deadlines, to deal with the issues efficiently, and deliver what is promised. The IHCRA is the one who needs to pay close attention to details while preparing and collecting study-specific documentation, receiving and complying with requests, and completing queries and updating tracking systems.

The work of the IHCRA involves close collaboration with a broad range of people, so you can sometimes face disagreements that need to be resolved. When that occurs, it helps to fully understand the other person’s perspective and you need to take time to listen to his or her point of view. Only then will you be able to work out a collaborative solution. It is critical for the IHCRA to have a reasonable and common sense approach to create the basis for an inclusive working platform to conduct clinical trials in a polite and a professional manner.

All in all, the IHCRA should keep pace with the rapid changes in the industry by completing trainings, taking tests, reading articles, watching news, asking questions, and discussing topics in the clinical trials network.

But in the end, it’s like what H. Jackson Brown, Jr., said: “Find a job you like and you add five days to every week.” Taking everything into account, I can say with certainty that I definitely did just that with clinical trials as an IHCRA. I’m convinced that I found where I belong.